BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT HCV EIA 2.0

    MDR report key: 634519 · Received June 14, 2005

    Report

    Report Number
    1415939-2005-00019
    Event Type
    Other
    Date Received
    June 14, 2005
    Date of Event
    May 9, 2005
    Report Date
    June 14, 2005
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A NONREACTIVE HCV EIA 2.0 RESULT ON A PATIENT WHO TESTED RIBA POSITIVE AND RNA POSITIVE. THE PHYSICIAN QUESTIONED THE NEGATIVE HCV EIA 2.0 RESULT AND ADDITIONAL HCV TESTING WAS PERFORMED DUE TO THE PATIENT CLINICAL PICTURE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ACCOUNT TESTING DATA: 05/2005 HCV EIA 2.0=0.181 S/CO, CUTOFF=0.444, 05/2005 HCV EIA 2.0=0.386 S/CO, CUTOFF=0.467, RERUN IN 05/2005 HCV EIA 2.0=0.434 S/CO, CUTOFF=0.456: EVALUATED LIVER ENZYMES, SPECIMENS WAS ICTERIC. REFERENCE LAB TESTING DATA: HCV RIBA POSITIVE, 3+ON TWO BANDS, HCV RNA DETECTED, HCV RNA QUANTITATIVE 18.2E6 IU/ML, REFERENCE=<50, HCV RNA QUANITITATIVE 7.26 LOG IU/ML, REFERENCE=<1.7, HCV GENOTYPING PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT HCV EIA 2.0 EIA FOR DETECTION OF HCV ANTIBODY LQI ABBOTT LABORATORIES NA 22201M201

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR